Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-26 @ 10:36 AM
Ignite Modification Date: 2025-12-26 @ 10:36 AM
NCT ID: NCT00507728
Description: None
Frequency Threshold: 1
Time Frame: Baseline, up to 8 months
Study: NCT00507728
Study Brief: Pharmacogenetics, Emotional Reactivity and Smoking
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Varenicline Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter). Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter) 0 None 2 75 63 75 View
Bupropion Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter). Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter) 0 None 2 89 69 89 View
Placebo Placebo by mouth for 12 weeks. Placebo: Placebo by mouth for 12 weeks. 0 None 0 90 66 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABSCESS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ACCIDENTAL INJURY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
APPETITE DECREASED SYSTEMATIC_ASSESSMENT General disorders None View
APPETITE INCREASED SYSTEMATIC_ASSESSMENT General disorders None View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abnormal Dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergy, Seasonal SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anxiety Symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
BLOOD IN STOOL SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
BRONCHITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BRUISE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Body odor SYSTEMATIC_ASSESSMENT General disorders None View
Cerebrospinal fluid.. SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disturbance in attention SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elevated mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emotional liability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Glucose intolerance SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Herniated Disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Increased Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection SYSTEMATIC_ASSESSMENT General disorders None View
Influenza SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Kidney Stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Libido decreased SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain SYSTEMATIC_ASSESSMENT General disorders None View
PARESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PNEUMONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT General disorders None View
Reduced inhibition SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SWEATING INCREASED SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sensory disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Surgical and medical SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
TASTE PERVERSION SYSTEMATIC_ASSESSMENT General disorders None View
TREMOR SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tachycardia/Palpita.. SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT General disorders None View
URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine abnormality SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View